U.S. patent number 10,814,086 [Application Number 15/120,380] was granted by the patent office on 2020-10-27 for sealing force detection enabled, therapeutic fluid delivery device.
This patent grant is currently assigned to Fisher & Paykel Healthcare Limited. The grantee listed for this patent is Fisher & Paykel Healthcare Limited. Invention is credited to Jeroen Hammer, Jonathan David Harwood, Fadi Karim Moh'd Mashal, Daniel John Smith, Matthew Roger Stephenson.
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United States Patent |
10,814,086 |
Mashal , et al. |
October 27, 2020 |
Sealing force detection enabled, therapeutic fluid delivery
device
Abstract
A respiratory mask can include one or a plurality of force
sensors configured to detect a force imparted to a user's skin.
Output from the one or more sensors can be represented in a way
useful to the patient or healthcare provider for adjusting the mask
to achieve a desired fitment. A representation of the detected
forces can be displayed on a separate display device or on the
mask.
Inventors: |
Mashal; Fadi Karim Moh'd
(Auckland, NZ), Stephenson; Matthew Roger (Auckland,
NZ), Hammer; Jeroen (Auckland, NZ), Smith;
Daniel John (Auckland, NZ), Harwood; Jonathan
David (Auckland, NZ) |
Applicant: |
Name |
City |
State |
Country |
Type |
Fisher & Paykel Healthcare Limited |
Auckland |
N/A |
NZ |
|
|
Assignee: |
Fisher & Paykel Healthcare
Limited (Auckland, NZ)
|
Family
ID: |
1000005139990 |
Appl.
No.: |
15/120,380 |
Filed: |
February 26, 2015 |
PCT
Filed: |
February 26, 2015 |
PCT No.: |
PCT/NZ2015/050020 |
371(c)(1),(2),(4) Date: |
August 19, 2016 |
PCT
Pub. No.: |
WO2015/130180 |
PCT
Pub. Date: |
September 03, 2015 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20170065784 A1 |
Mar 9, 2017 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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61945001 |
Feb 26, 2014 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M
16/0616 (20140204); A61M 16/0683 (20130101); A61M
2205/502 (20130101); A61M 2205/35 (20130101); A61B
5/6803 (20130101); A61M 2205/332 (20130101); A61B
5/6843 (20130101) |
Current International
Class: |
A61M
16/06 (20060101); A61B 5/00 (20060101) |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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2478839 |
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Jul 2012 |
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EP |
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3033130 |
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Oct 2017 |
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EP |
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WO 2013/183018 |
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Dec 2013 |
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WO |
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WO 2014/024086 |
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Feb 2014 |
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WO |
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WO 2015/002652 |
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Jan 2015 |
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WO |
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WO 2015/022595 |
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Feb 2015 |
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WO |
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WO 2015/130180 |
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Sep 2015 |
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WO |
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Other References
International Search Report; PCT/NZ2015/050020; dated Apr. 27,
2015. cited by applicant .
GB Examination Report; GB1713996; dated Nov. 28, 2017; 5 pages.
cited by applicant .
GB Examination Report; GB1713995; dated Nov. 27, 2017; 5 pages.
cited by applicant .
AU Examination Report; AU 2015223574; dated Nov. 20, 2018; 4 pages.
cited by applicant.
|
Primary Examiner: Dixon; Annette
Attorney, Agent or Firm: Knobbe Martens Olson and Bear,
LLP
Claims
The invention claimed is:
1. A respiratory mask configured to seal with a face of a patient,
the respiratory mask comprising: a seal portion comprising a
sealing surface configured to form a seal long a perimeter
encircling at least one respiratory orifice of the face of the
patient; and a head strap assembly configured to secure the seal
portion in contact with the perimeter, the head strap assembly
comprising: at least one tension adjustment assembly, wherein each
tension adjustment assembly comprises: a sensor body configured to
detect a force in the head strap assembly, the sensor body
comprising an elastic capacitive sensor, a first portion including
a first end and a second end, the first end including an engagement
portion for engaging a first portion of the head strap assembly and
the second end including a sensor retaining clip configured to
retain an end of the sensor body to the first portion, a second
portion including a first end and a second end, the second end
configured to engage a second portion of the head strap assembly
and the first end including a sensor engagement portion configured
to retain a second opposite end of the sensor body to the second
portion, and wherein a second end of the first portion is
configured to engage with a first end of the second portion,
wherein the sensor body is retained between the second end of the
first portion and the first end of the second portion.
2. The respiratory mask according to claim 1, wherein the at least
one elastic sensor is configured to detect a tension in the head
strap assembly.
3. The respiratory mask according to claim 1, wherein the head
strap assembly comprises a plurality of strap members, the at least
one tension adjustment assembly is removably attached to one of the
plurality of strap members.
4. The respiratory mask according to claim 1, further comprising at
least one elastic force sensor configured to detect a force applied
to the seal portion.
5. The respiratory mask according to claim 1, further comprising at
least a second elastic sensor configured to detect a force in the
head strap assembly.
6. The respiratory mask according to claim 1, wherein the at least
one tension adjustment assembly is configured to connect the first
portion and the second portion of the head strap assembly.
7. The respiratory mask according to claim 6, wherein the at least
one tension adjustment assembly comprises a first end connected to
the first portion of the head strap assembly and a second end
connected to the second portion of the head strap assembly, the
elastic sensor being connected between the first and second ends
such that the elastic sensor is stretched when the first end and
the second end are pulled away from each other by the first portion
and the second portion of the head strap assembly.
8. The respiratory mask according to claim 7, wherein the at least
one tension adjustment assembly is removable from the head strap
assembly.
9. The respiratory mask according to claim 7, wherein the at least
one tension adjustment assembly comprises a sensor module connected
to the elastic sensor, the sensor module comprising a sensor
driver, a power supply, and a wireless communication device
configured to wirelessly transmit a signal indicative of an output
of the at least one tension adjustment assembly.
Description
INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS
Any and all applications for which a foreign or domestic priority
claim is identified in the Application Data Sheet as filed with the
present application are hereby incorporated by reference under 37
CFR 1.57.
TECHNICAL FIELD
The present embodiments relate to therapeutic fluid delivery
devices, including, for example, therapeutic masks with sealing
force detection.
BACKGROUND
Fluid delivery devices which include a sealing device providing a
seal with a patient's skin, often in the form of a butting seal,
are used for a variety of different therapies. Some of this type of
therapeutic fluid delivery devices are designed for delivering
breathable gasses, for example, including but not limited to
non-invasive ventilation, oxygen therapy and continuous positive
airway pressure (CPAP), for the treatment of various respiratory
conditions. Many of these respiratory therapies are better
administered and more effective when a substantially airtight seal
is achieved between the mask and the user.
The contours of different patient's skin vary, and thus, fluid
delivery devices are typically made to fit a variety of
differently-shaped faces. However, due to the range of differing
anatomical geometries in the human population, it can be difficult
to achieve a desired seal on every patient. This is especially true
in the context of fluid delivery devices in the form of respiratory
masks; a result of the variability of the geometry of different
patient's faces in the areas surrounding the nose and/or mouth.
In the context of respiratory masks, it is common to apply
substantial forces to a mask and user's face in an attempt to
overcome sealing challenges presented by the depth and variation of
facial contours, for example, in the areas around the bridge of the
nose. The application of forces to a mask and thus a user's face
can cause discomfort as well as injuries to the user and is not
always successful at attaining satisfactory leak rates.
For example, FIGS. 1 and 2 illustrate skin sores caused by existing
respiratory masks. In some cases, the patient is not conscious or
lucid and thus not able to indicate discomfort or pain that may
precede such injuries.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide a therapeutic
fluid delivery devices, including, for example, therapeutic masks
with sealing force detection, that will at least go some way
towards improving on the above or which will at least provide the
public or the medical profession with a useful choice.
An aspect of at least one of the embodiments disclosed herein
includes the realization that patient comfort can be improved and
patient injuries caused by masks can be reduced by providing for
the detection and display of forces imparted onto a patient's skin
at the location of the seal of the mask. For example, by detecting
the forces imparted onto a patient's face at the seal of a mask,
then displaying a representation of the detected force, a patient
or healthcare provider can identify whether a mask has been applied
in a non-optimal manner, then adjust the mask to correct the
application of the mask.
This can provide significant benefits with regard to the use of
various kinds of masks, including reducing the number of leaks
and/or the leak rate to acceptable magnitudes or eliminate leaks
altogether. Such mask features can also reduce forces on the user's
skin ("skin pressure"), in particular, areas of the face where the
skin is thin such as the nasal bridge, for example. Additionally,
force detection can lead to a determination that a particular mask
cannot be adjusted to produce a desired leak rate without using
excessive application force, and thus, different mask should be
considered.
Designing such masks presents several challenges, including
accommodating differently sized and shaped faces, as well as
minimizing the force of contact between the seal and the
corresponding portions of each different user's face. Ideally, a
mask will not leak with very low skin pressure. Leaks will occur,
however, where the skin pressure is insufficient to counter the
gaseous pressure differential between the inside and outside of the
mask. Thus, when unacceptable leaking is found using a typical
mask, the force on the entire mask (e.g., by way of a strap) is
typically increased until leaks are reduced to an acceptable level
or eliminated. However, such additional force also increases the
force of contact between the seal and the user's face (skin
pressure) at locations where no leaking occurred, thereby
generating unnecessarily higher forces at some locations, which can
cause discomfort and/or injury.
FIGS. 1 and 2 schematically illustrate facial skin injuries
suffered by patients who wore respiratory masks while receiving
medical care. FIG. 1 illustrates a more generalized, inverted
U-shaped injury 10 extending from the patient's cheeks and up and
over the bridge of the nose. As shown in FIG. 1, the injury 10
includes larger regions 12, 14 lower down on the user's face and
another larger portion 16 on the bridge of the patient's nose.
Additionally, there are thinner, smaller regions 18, 20 lower down
on the user's face, between the nose bridge injury area 16 and the
lower larger portions 12, 14. As such, it appears that the mask
causing this injury generated uneven forces around the patient's
cheeks and nose bridge.
FIG. 2 illustrates a highly localized injury 22 appearing only on
the bridge of the nose of the patient. More severe injuries, such
as that illustrated in FIG. 2, are more common in areas of the face
where the skin is thin, i.e. where bone is close to skin i.e. the
nasal bridge. These are the areas of the face that experience the
highest loads due to over tightening the headgear straps of the
mask system. Excessive skin pressure can restrict blood flow,
thereby starving the skin tissue of oxygen and nutrients and
accelerating breakdown of the skin tissue.
An aspect of at least one of the embodiments disclosed herein
includes the realization that misapplication of a mask, which may
cause leaks, injury, or discomfort, can be due to a misalignment of
the mask with the patient's face, characterized by excessive,
non-uniform pressure along the seal-skin contact area.
In this context, an "optimal" alignment or fitment of a mask with a
user's face would be the alignment and strap tension that results
in an acceptable leak rate or no leak, where the skin pressure
exerted on the patient's face along the sealing surface of the mask
is the most uniform and at the lowest magnitude. However, detecting
nonuniformity of the skin pressure is difficult for a patient to
sense and resolve when applying a mask to their own face.
Additionally, a healthcare provider cannot perceive the skin
pressure when applying a mask to a patient, particularly when the
patient is unconscious or not sufficiently lucid to assist.
Thus, in accordance with an embodiment, a therapeutic fluid
delivery device includes a seal and is configured to detect a force
between the seal and a target area of a patient's body. The seal
portion can comprise a sealing surface configured to form a seal
with a patient's skin along a perimeter encircling the target area
of the patient. The fluid delivery device can also include at least
a plurality of sensors configured to detect a force imparted to the
patient's skin by the sealing surface.
By including at least a plurality of sensors, a force differential
can be determined. For example, where the force of one sensor is
greater than the force detected by the other sensor, a force
nonuniformity is detected. A patient or healthcare provider could
use the detection of such a nonuniformity as a guide to adjusting
the fluid delivery device to achieve a better fitment.
Thus, in accordance with another embodiment, a mask can include a
seal portion and can be configured to detect a force between the
seal portion and an area of the patient's skin encircling at least
one respiratory orifice of a patient. The seal portion can comprise
a sealing surface configured to form a seal with a patient's skin
along a perimeter encircling the at least one respiratory orifice.
The mask can also include at least a plurality of sensors
configured to detect a force imparted to the patient's skin by the
sealing surface.
In accordance with another embodiment, a respiratory mask fitment
system can include a mask including a seal portion comprising a
sealing surface configured to form a seal with the skin of a human
face along the perimeter encircling at least one respiratory
orifice of the patient. A first sensor can be configured to detect
a first force applied to the seal portion and to output a first
data indicative of the force detected by the sensor. A display
system including a display device can be connected to the sensor
and configured to display a representation of the first data.
By providing a system that can display a representation indicative
of pressure exerted by a mask seal against the face of a patient,
the patient or healthcare provider can observe the force detected
and use that information for achieving a better fitment of the
mask.
In accordance with another embodiment, a method of fitting a mask
on a patient can include placing a mask having a seal portion over
a respiratory orifice of a patient. The method can also include
detecting a force imparted to the seal portion at a first location
and displaying a representation of the force on a display device.
The method can also include adjusting the mask based on the
displayed force.
In some configurations, a respiratory mask includes a seal and is
configured to detect a force between the seal and a human face. The
mask can comprise a seal portion comprising a sealing surface
configured to form a seal with face along a perimeter encircling at
least one respiratory orifice of a human. A plurality of sensors
can be configured to detect a force applied to the seal
portion.
In some configurations, the plurality of elastic sensors comprises
at least a first sensor configured to detect a force at a first
location on the seal portion, and a second sensor configured to
detect a force at a second location on the seal portion different
than the first location.
In some configurations, the plurality of sensors are configured to
detect forces applied by the sealing surface to a portion of the
human face and/or head.
In some configurations, the seal portion further comprises a
cushion, the plurality of sensors being configured to detect
compression of the cushion.
In some configurations, the plurality of sensors are configured to
output signals indicative of force applied to the seal portion
caused by deformation of the sensors.
In some configurations, the plurality of sensors are configured to
detect deformation of the sensors and to output signals in response
to the deformation.
In some configurations, a display system includes a display device
configured to display representations of the forces detected by the
plurality of sensors.
In some configurations, the display system is configured to display
the representations of forces detected by the plurality of sensors
and a graphical representation of the seal portion.
In some configurations, the display system is configured to display
the graphical representation of the seal portion corresponding to a
front elevational view of the mask.
In some configurations, the display system is configured to display
the graphical representation of the seal portion corresponding to a
rear elevational view of the mask.
In some configurations, the display system is configured to display
data indicative of magnitudes forces detected by the plurality of
sensors in real time.
In some configurations, the display device is disposed on the
mask.
In some configurations, the display device comprises a plurality of
lights positioned proximate to the plurality of sensors,
respectively.
In some configurations, a recording device is configured to store
output from the plurality of sensors.
In some configurations, the plurality of sensors comprise elastic
capacitive sensors.
In some configurations, the plurality of sensors comprise layered
capacitive sensors.
In some configurations, the plurality of sensors comprise a first
longitudinal layer including a first electrode and second and third
transverse layers including second and third electrodes overlapping
the first electrode, wherein the first and second electrodes form a
first capacitive sensor and the first and third electrodes for a
second capacitive sensor.
In some configurations, one of the plurality of sensors comprise
layered first, second, and third electrodes, the first and second
electrode forming a first pair of electrodes with a first
capacitance and the second and third electrodes forming a second
pair of electrodes with a second capacitance.
In some configurations, the plurality of sensors comprise a first
force sensor disposed on an outer side of the sealing surface and a
second force sensor disposed on an inner side of the sealing
surface.
In some configurations, the plurality of sensors comprise a first
row of force sensors extending along a longitudinal direction of
the seal portion and a second row of force sensors extending
parallel to the first row.
In some configurations, a first of the plurality of sensors
comprises first and second electrodes spaced apart by a dielectric
layer, the first electrode comprising conductive silicone.
In some configurations, at least a first of the plurality of
sensors comprises first and second electrodes spaced apart by a
dielectric layer, the dielectric layer comprising silicone.
In some configurations, at least a first of the plurality of
sensors comprises first and second electrodes spaced apart by a
dielectric layer, wherein at least one of the dielectric layer and
the first and second electrodes comprises silicone, and wherein the
seal portion comprises silicone.
In some configurations, the seal portion being mounted to a frame
portion, wherein at least a first of the plurality of sensors is
disposed between the seal portion and the frame portion.
In some configurations, the plurality of sensors are positioned to
detect forces proximate to a bridge of a human nose during use.
In some configurations, at least one of the plurality of sensors is
positioned to detect a force proximate to a chin of a human during
use.
In some configurations, a display system can include a display
device configured to display representations of the forces detected
by the plurality of sensors.
In some configurations, a respiratory mask fitment system can
comprise a mask including a seal portion comprising a sealing
surface configured to form a seal with skin of a human face along a
perimeter encircling at least one respiratory orifice of a human. A
first elastic sensor can be configured to detect a first force
applied to the seal portion and to output first data indicative of
a force detected by the sensor. Additionally, a display system can
include a display device, the display system being connected to the
first sensor and configured to display a first representation of
the first data.
In some configurations, a second sensor can be configured to detect
a second force applied to the seal portion and to output second
data indicative of a second force detected by the second sensor,
wherein the first sensor is configured to detect a force at a first
location on the seal portion, and a second sensor configured to
detect a force at a second location on the seal portion different
than the first location.
In some configurations, the device is configured to display the
pressures detected by the plurality of sensors and a graphical
representation of the seal portion.
In some configurations, the display system is configured to display
the graphical representation of the seal portion corresponding to a
front elevational view of the mask.
In some configurations, the display system is configured to display
the graphical representation of the seal portion corresponding to a
rear elevational view of the mask.
In some configurations, the display system is configured to display
data indicative of magnitudes forces detected by the first sensor
in real time.
In some configurations, the display device is disposed on the
mask.
In some configurations, a memory device can be configured to record
output from the first elastic sensor.
In some configurations, the display device is connected to the
first sensor wirelessly.
In some configurations, the first sensor comprises a layered
capacitive sensor.
In some configurations, the first sensor comprises a first
longitudinal layer including a first electrode and second and third
transverse layers including second and third electrodes overlapping
the first electrode, wherein the first and second electrodes form a
first capacitive sensor and the first and third electrodes for a
second capacitive sensor.
In some configurations, first and second force sensors can be
aligned with each other.
In some configurations, the first force sensor is disposed on an
outer side of the sealing surface and the second force sensor is
disposed on an inner side of the sealing surface.
In some configurations, a first row of force sensors can include
the first sensor and can extend along a longitudinal direction of
the seal portion with a second row of force sensors extending
parallel to the first row.
In some configurations, the first force sensor comprises first and
second electrodes spaced apart by a dielectric layer, the first
electrode comprising conductive silicone.
In some configurations, the first force sensor comprises first and
second electrodes spaced apart by a dielectric layer, the
dielectric layer comprising silicone.
In some configurations, the seal portion can be mounted to the
frame portion, wherein the first sensor is disposed between the
seal portion and the frame portion.
In some configurations, the display device comprises a first
light.
In some configurations, the first light is positioned proximate to
the first sensor.
In some configurations, a second sensor can be configured to detect
a force on the seal portion and a second light.
In some configurations, the first sensor comprises layered first,
second, and third electrodes, the first and second electrode
forming a first pair of electrodes with a first capacitance and the
second and third electrodes forming a second pair of electrodes
with a second capacitance.
In some configurations, the seal portion comprises a right-side
configured to seal against a right side of a patient's face and a
left side configured to seal against a left side of a patient's
face, the first and second rows of sensors being disposed on the
right side of the seal portion.
In some configurations, the first force sensor comprises first and
second electrodes spaced apart by a dielectric layer, wherein at
least one of the dielectric layer and the first and second
electrodes comprises silicone, and wherein the seal portion
comprises silicone.
In some configurations, a method of fitting a mask on a patient can
comprise placing a mask having a seal portion over a respiratory
orifice of a patient, detecting a first force imparted to the seal
portion at a first location based on deformation of the seal
portion, displaying a first representation of the first force on a
display device, and adjusting the mask.
In some configurations, the method also includes detecting a second
force on the seal portion at a second location.
In some configurations, displaying a first representation comprises
displaying a graphical representation of the mask and displaying
the first representation on the graphical representation.
In some configurations, adjusting the mask comprises tightening or
loosening at least one strap holding the mask on the patient.
In some configurations, the method can also include detecting at
least second and third forces imparted to second and third
locations on the seal portion, the first, second and third
locations being proximate to a bridge of a patient's nose.
In some configurations, at least one of the first and second
locations are proximate to a chin of a patient.
In some configurations, the method can also include detecting
forces at a plurality of additional locations, the first location
and additional locations forming an array of approximately
evenly-spaced locations encircling the respiratory orifice.
In some configurations, the method can also include displaying a
second representation of the second force.
In some configurations, adjusting the mask comprises changing a
shape of the mask.
In some configurations, a respiratory mask can include a seal for
sealing with a human face and can comprise a seal portion
comprising a sealing surface configured to form a seal along a
perimeter encircling at least one respiratory orifice of a human. A
head strap assembly can be configured to secure the seal portion in
contact with the perimeter, and at least one elastic sensor can be
configured to detect a force in the head strap assembly.
In some configurations, the at least one elastic sensor is
configured to detect a tension in the head strap assembly.
In some configurations, the head strap assembly comprises a
plurality of strap members, the at least one elastic sensor being
integrated into one of the plurality of strap members.
In some configurations, at least one elastic force sensor can be
configured to detect a force applied to the seal portion.
In some configurations, at least a second elastic sensor can be
configured to detect a force in the head strap assembly.
In some configurations, the head strap assembly comprises a first
clip connecting first and second portions of the head strap
assembly, wherein the at least one elastic sensor is incorporated
into the clip.
In some configurations, the first clip comprises a first end
connected to the first portion of the head strap assembly and a
second end connected to the second portion of the head strap
assembly, the at least one elastic sensor being connected between
the first and second ends such that the at least one elastic sensor
is stretched when the first and second ends are pulled away from
each other by the first and second portions of the head strap
assembly.
In some configurations, the first clip is removable from the head
strap assembly.
In some configurations, the first clip comprises a sensor module
connected to the first elastic sensor, the sensor module comprising
a sensor driver, a power supply, and a wireless communication
device configured to wirelessly transmit a signal indicative of an
output of the at least one elastic sensor.
In some configurations, a respiratory mask assembly can have a mask
portion and head strap assembly and can comprise a mask portion
comprising a sealing surface configured to form a seal along a
perimeter encircling at least one respiratory orifice of a human, a
head strap assembly configured to secure the mask portion in a
position over the at least one respiratory orifice, a first
plurality of elastic sensors configured to detect forces in the
head strap assembly, respectively, and a second plurality of
elastic sensors configured to detect forces in the mask
portion.
In some configurations, the second plurality of elastic sensors are
configured to detect deformation of the sealing surface.
In some configurations, the mask portion comprises a cushion
portion disposed adjacent to the sealing surface, the second
plurality of elastic sensors being configured to detect deformation
of the cushion portion.
In some configurations, a therapeutic fluid delivery device having
a seal and configured to detect a force between the seal and a
patient can comprise a seal portion comprising an outer sealing
surface configured to form a seal with an area of a patient's skin
encircling at least one target area of a patient, and at least a
first elastic capacitive sensor configured to output a signal in
response to a force imparted to the outer sealing surface.
In some configurations, the first elastic capacitive sensor is
configured to output signals indicative of a range of force
magnitudes imparted to the outer sealing surface.
In some configurations, the first elastic capacitive sensor is
configured to output signals in a predetermined proportional
relationship with the range of force magnitudes imparted to the
outer sealing surface.
In some configurations, the first elastic capacitive sensor can be
configured to detect a force at a first location on the sealing
surface, and a second sensor can be configured to detect a force at
a second location on the sealing surface spaced from the first
location.
In some configurations, the seal portion is configured to extend
around at least one respiratory orifice of a patient and the first
elastic capacitive sensor is configured to detect forces between
the sealing surface and the skin of a human face.
In some configurations, the seal portion further comprises a
cushion layer disposed inwardly from the sealing surface, the first
elastic capacitive sensor being embedded in the cushion layer.
In some configurations, first and second first elastic capacitive
sensors can be positioned to detect forces proximate to a bridge of
a human nose during use.
In some configurations, at least one of first and second elastic
capacitive sensors are positioned to detect a force proximate to a
chin of a human during use.
In some configurations, a display system can include a display
device configured to display representations of the forces detected
by the first elastic capacitive sensor.
In some configurations, the display system is configured to display
forces detected by the first elastic capacitive sensor and a
graphical representation of the seal portion.
In some configurations, the display system is configured to display
the graphical representation of the seal portion corresponding to a
front elevational view of the mask.
In some configurations, the display system is configured to display
the graphical representation of the seal portion corresponding to a
rear elevational view of the mask.
In some configurations, the display system is configured to display
data indicative of magnitudes forces detected by the first elastic
capacitive sensor in real time.
In some configurations, the display device is disposed on the
mask.
In some configurations, the display device comprises a plurality of
lights.
In some configurations, at least a second sensor can be configured
to output a signal in response to a force imparted to the outer
sealing surface, wherein the plurality of lights are positioned
proximate to the first and second sensors, respectively.
In some configurations, the first sensor comprises a layered
capacitive sensor.
In some configurations, the first sensor comprises a first
longitudinal layer including a first electrode and second and third
transverse layers including second and third electrodes overlapping
the first electrode, wherein the first and second electrodes form a
first capacitive sensor and the first and third electrodes for a
second capacitive sensor.
In some configurations, the first sensor comprises layered first,
second, and third electrodes, the first and second electrode
forming a first pair of electrodes with a first capacitance and the
second and third electrodes forming a second pair of electrodes
with a second capacitance.
In some configurations, first and second force sensors can be
aligned with each other.
In some configurations, the first force sensor is disposed on an
outer side of the sealing surface and the second force sensor is
disposed on an inner side of the sealing surface.
In some configurations, a first row of force sensors including the
first sensor, extends along a longitudinal direction of the seal
portion and a second row of force sensors extends parallel to the
first row.
In some configurations, the seal portion comprises a right-side
configured to seal against a right side of a patient's face and a
left side configured to seal against a left side of a patient's
face, the first and second rows of sensors being disposed on the
right side of the seal portion.
In some configurations, the first force sensor comprises first and
second electrodes spaced apart by a dielectric layer, the first
electrode comprising conductive silicone.
In some configurations, the first force sensor comprises first and
second electrodes spaced apart by a dielectric layer, the
dielectric layer comprising silicone.
In some configurations, the first force sensor comprises first and
second electrodes spaced apart by a dielectric layer, wherein at
least one of the dielectric layer and the first and second
electrodes comprises silicone, and wherein the seal portion
comprises silicone.
In some configurations, the seal portion can be mounted to a frame
portion, wherein the first sensor is disposed between the seal
portion and the frame portion.
The term "comprising" is used in the specification and claims,
means "consisting at least in part of". When interpreting a
statement in this specification and claims that includes
"comprising", features other than that or those prefaced by the
term may also be present. Related terms such as "comprise" and
"comprises" are to be interpreted in the same manner.
In this specification where reference has been made to patent
specifications, other external documents, or other sources of
information, this is generally for the purpose of providing a
context for discussing the features of the invention. Unless
specifically stated otherwise, reference to such external documents
is not to be construed as an admission that such documents, or such
sources of information, in any jurisdiction, are prior art, or form
part of the common general knowledge in the art.
BRIEF DESCRIPTION OF THE DRAWINGS
FIGS. 1 and 2 are schematic front elevational views of a patient's
face showing injuries caused by known masks.
FIG. 3 is a schematic perspective and exploded view of a patient
and a therapeutic fluid delivery device in accordance with an
embodiment.
FIG. 4 is a perspective view of an embodiment of the device of FIG.
3, in the form of a respiratory mark fitted on a patient and
including a head strap assembly.
FIG. 5 is a rear elevational view of the mask of FIG. 4 with the
straps removed.
FIG. 6a is a rear elevational view of a modification of the mask
illustrated in FIG. 5.
FIG. 6b is a perspective view of a modification of the mask
illustrated in FIG. 6a.
FIG. 6c is a perspective view of a modification of the mask and
head strap assembly of FIG. 4, including optional sensors at
various locations on the head strap assembly.
FIG. 6d is a perspective view of a modification of the frame and
seal assembly of the mask of FIG. 6c, including optional
sensors.
FIG. 6e is an enlarged view of a portion of the head strap assembly
of the mask of FIG. 6c illustrating an optional removable sensor
assembly.
FIG. 6f is an enlarged perspective and exploded view of an optional
technique for using the sensor assembly illustrated in FIG. 6d.
FIG. 6g is an enlarged perspective and partial cut-away view of an
optional structural for mounting a sensor in the head strap of the
mask of FIG. 6c.
FIG. 6h is an enlarged perspective view of an optional mounting
arrangement of a sensor with the head strap of the mask of FIG.
6c.
FIG. 6i is an enlarged perspective view of two alternative mounting
locations for a sensor on the head strap of the mask of FIG.
6c.
FIG. 6j is an enlarged perspective of an optional arrangement for
mounting a sensor to the head strap with the sensor being disposed
between outer layers of a head strap.
FIG. 6k is a perspective, partial wire frame view of a head strap
clip that can be used with the mask of FIG. 6c and including a
sensor.
FIG. 6l is a perspective exploded view of the clip of FIG. 6k.
FIG. 6m is a perspective view of a modification of the clip of FIG.
6k.
FIG. 7 is a perspective view of another embodiment of the mask, in
the configuration of an oral mask.
FIG. 8 is a rear elevational view of the mask of FIG. 7.
FIG. 9 is a perspective view of another modification of the mask in
the configuration of a nasal pillow mask.
FIG. 10 is a skewed view of the nasal mask, as viewed along the
direction identified by the arrow 410 in FIG. 9.
FIG. 11 is a sectional view of an elastic capacitive sensor, in a
neutral state, that can be used with any of the masks of FIGS.
3-12.
FIG. 12 is a sectional view of the sensor of FIG. 11 in a deformed
state.
FIG. 12a is a further sectional view of the sensor of FIG. 11 bent
in a neutral state, prior to connection to another surface.
FIG. 12b is a further sectional view of the sensor of FIG. 11, bent
and connected to another surface.
FIG. 12c is a schematic perspective view of a modification of the
sensor of FIG. 11 in a layered configuration and including
interleaved electrodes.
FIG. 12d is a schematic view of the sensor of FIG. 12c illustrating
electrical connections of interleaved electrodes.
FIG. 12e is a schematic side elevational view of another optional
sensor component configuration.
FIG. 12f is a schematic side elevational view of a combination of
plural sensor components of FIG. 12e.
FIG. 12g is a schematic perspective view of a sensor arrangement
formed of one sensor component overlapped by four transverse sensor
components.
FIG. 12h is a schematic side elevational view illustrating
overlapping portions of the sensor arrangement of FIG. 12g.
FIG. 12i is a top plan view of the overlapping arrangement of FIG.
12h.
FIG. 13a is a schematic, perspective and sectional view of a
portion of the mask of FIG. 4 illustrating optional external sensor
mounting locations on the mask.
FIG. 13b is a schematic, enlarged sectional view of the mask of 13a
illustrating an external mounting arrangement for a sensor.
FIG. 13c is an enlarged sectional view of the mask of FIG. 13a
illustrating a partially embedded external mounting arrangement for
the sensor.
FIG. 13d is an enlarged sectional view of the mask of FIG. 13a
illustrating a flush, external mounting arrangement for the
sensor.
FIG. 14a is a schematic and perspective cross-sectional view of a
portion of the mask of FIG. 4 illustrating a dual-sensor mounting
arrangement.
FIG. 14b is an enlarged sectional view of the mask of FIG. 14a
illustrating a pair of sensors, one mounted on an external side
with the sealing portion of the mask and one sensor mounted on an
interior side.
FIG. 14c is an enlarged sectional of the mask of FIG. 14a
illustrating a modification of the arrangement of FIG. 14b
including a partially or flush mounted exterior side sensor and a
partially embedded or flush mounted interior side sensor.
FIG. 14d is an enlarged cross-sectional view of a frame-seal
interface mounting arrangement for a sensor that can be used in the
mask of FIG. 14a.
FIG. 15a is an enlarged schematic and sectional view of three
optional sensor mounting locations for embodiments of the mask of
FIG. 14a, including a cushion or gel portion.
FIG. 15b is another enlarged schematic sectional view of an
alternative sensor mounting location for a mask incorporating a
cushion-type seal.
FIG. 16 is a schematic diagram of a fitment system including any of
the fluid delivery device embodiments disclosed above and a display
device.
FIG. 17 is a schematic diagram illustrating a wireless embodiment
of the fitment system of FIG. 16, including a wireless display
device.
FIG. 18 is a schematic illustration of a display for displaying
information indicative of forces detected by the force sensors, in
a front elevational view orientation.
FIG. 19a is a schematic illustration of a graphical representation
of force in a rear elevational view orientation.
FIG. 19b is a schematic illustration of another optional graphical
representation of force including a three-dimensional force
map.
FIG. 19c is schematic illustration of another optional format for
representing force information on a user interface, including a
circular arrangement of pressure readings, optionally color coded
and with an optional reticle-style balance visualizer.
FIG. 19d is a schematic representation of a modification of the
format of FIG. 19c, including selective presentations of pressure
readings and a movable reticle representing force balance.
FIG. 19e is schematic illustration of another optional format for
representing force data including a horizontally extending bar
graph having a pressure value associated with the nose bridge in
the center and with the left and right adjacent sensor readings
extending toward the left and right, respectively.
FIG. 19f is another optional format for representing force data
including left and right pluralities of force representations
arranged in two parallel, vertical groupings, with the forces
proximate to the nose at the top and forces proximate to the chin
at the bottom.
FIG. 19g is another optional format for representing force data in
the form of a circular arrangement with force magnitudes
represented on radially varying bar graphs.
FIG. 20 is a perspective view of another modification of the fluid
delivery device including a display device.
FIG. 21 is a schematic diagram of the fluid delivery device of FIG.
20 with an included display device.
FIG. 22 is a flow chart illustrating an optional method for using
any of the masks described above.
DETAILED DESCRIPTION
The embodiments described below are described in the context of
therapeutic fluid delivery devices which include seals designed to
form seals with areas of patients encircling a target treatment
area. However, the inventions disclosed herein can be applied to
other devices designed for uses in other environments, including
devices for non-medical uses, and uses on non-humans, and/or
inanimate objects.
FIG. 3 schematically illustrates an embodiment of a therapeutic
fluid delivery device 100 including at least one force sensor 110
configured to detect a force imparted onto a patient at the
seal-skin interface. As used herein, the term "force" is intended
to encompass either a load or a pressure.
The fluid delivery device 100 can include a frame 102, a seal
portion 104 and a conduit connection 106. The frame 102 can be
configured to extend over a target portion R of a patient to be
treated with the fluid delivery device 100. For example, but
without limitation, the target area R can be an area of the
patient's body, such as the patient's skin with an undesirable
characteristic, such as disease, an incision, a wound or at least
one respiratory orifice of a patient, which can be, for example but
without limitation, the nostrils, nose, and/or mouth of a
patient.
The conduit connection 106 can be in the form of a connection for
receiving or discharging fluids or solids including those intended
for therapies. For example, the conduit connection 106 can be in
the form of a respiratory conduit connection, which can optionally
be incorporated into an aperture of the frame 102 to provide
connection to a respiratory air conduit. The fluid conduit 108 can
be of the type for supplying any type of fluids or solids intended
for therapeutic uses, such as a flow of pressurized breathable
gases to the fluid delivery device 100. Optionally, the fluid
delivery device 100 can include a strap assembly 112 for securement
to a patient.
The fluid delivery device 100, as noted above, can be configured
for providing a sealing arrangement with respect to a target
portion R of the patient's body, such as the skin, or one or any
combination of a patient's respiratory orifices, such as one or
both nostrils (e.g., nasal masks), the mouth (oral masks),
tracheotomy incisions, as well as other types of wounds, incisions,
orifices, or areas to be treated with the fluid delivery device
100. As such, the seal portion 104 can include a sealing surface
105 configured to generate a seal with an area or portion of the
patient AS surrounding any one or any combination of the target
portions R noted above. The portion AS can be in the form of skin,
hair, with or without or other structures intended to be left in
place during use of the mask 100, such as a nasogastric tube.
Additionally, in any of the above noted configurations, the fluid
delivery device 100 can also include one or any combination of the
various features disclosed herein, including various types of
sensor, sensor configurations, sensor orientations, and other
concepts described in greater detail below.
The sensor 110 can be any type of force sensor and can be mounted
to the seal portion 104 or the frame 102. The force sensor 110 can
be configured to detect a force imparted onto an area AS by the
seal portion 104. For example, the force sensor 110 can be
configured to detect a force imparted to the sealing surface 105 by
way of contact with the area AS.
Optionally, the fluid delivery device 100 can include a plurality
of sensors 110 disposed in different locations. For example, the
plurality of sensors 110 can be positioned at different locations
on the frame 102 and/or the seal 104. The sensor 110 can be
configured to detect a force imparted onto the fluid delivery
device 100, such as forces imparted onto the sealing surface 105,
by way of contact with the area AS, and to output a signal
indicative of the detected force. Further, optionally, the fluid
delivery device 100 can include one or more sensors associated with
the strap assembly 112, illustrated as sensor 110 in phantom line,
for detecting forces associated with holding the fluid delivery
device 100 against the patient.
The sensor 110 can also be connected to driver electronics (not
shown) configured to convert the signal from the sensor 110 to a
value indicative of the detected force. Optionally, and described
in greater detail below, the driver electronics can be connected to
a display device for displaying a representation of the detected
force in any format.
FIG. 4 illustrates an embodiment of the fluid delivery device 100
of FIG. 3, in the form of a respiratory mask, identified generally
by the reference numeral 200. Parts, features and components of the
mask 200 that correspond to the same or similar parts, features and
components of the fluid delivery device 100 are identified with the
same reference numeral except that a 100 has been added
thereto.
In the embodiment of FIG. 4, the mask 200 includes a frame portion
202 and seal portion 204 that are configured to extend over both
the mouth and the nose of a patient. Thus, the target area R of the
mask 200 is the nose and mouth of the patient.
The sealing surface 205 can be configured to form a seal with the
area of skin AS (FIG. 3) which extends over the bridge of the
patient's nose and around the mouth in a generally teardrop shaped
configuration, as is well known in the art. The respiratory conduit
208 can deliver a therapeutic fluid, such as breathable gasses, to
the patient by passing through the conduit connector 206, into the
frame portion 202 and into the space between the patient's face,
the frame portion 202 and the surrounding seal portion 204.
Additionally, the mask 200 can include a strap arrangement 212
configured for retaining the mask 200 against a patient's face.
With reference to FIG. 5, in some embodiments, the seal portion 204
of the mask 200 can include a plurality of sensors 220, 222, and
224 proximate to the nose bridge portion of the mask 200. As viewed
in FIG. 5, the sensor 220 would be proximate to the right side of
the bridge of the patient's nose, sensor 224 would be on the left
side of the bridge of the patient's nose, and the sensor 222 would
be positioned proximate to the top of the bridge of the patient's
nose. Additionally, optionally, the mask 200 can include a sensor
226 disposed at a lower portion of the seal portion 204 proximate
to a patient's chin during use. Each of the sensors 220, 222, 224,
226 can be configured to detect a force imparted to the patient's
skin by the portion of the sealing surface 205 at the respective
locations or proximate to the respective locations of the sensors
220, 222, 224, 226.
In some embodiments, the mask 200 includes at least two of the
sensors 220, 222, 224, 226. By incorporating at least two sensors
into the mask 200, differences in the forces applied to the
patient's skin can be detected and used to assist fitment of the
mask 200 onto a patient. Thus, in some embodiments, the mask 200
includes a plurality of sensors, for example, sensors 220, 222, and
224 proximate to the nose bridge portion of the mask. As such,
force differences around the bridge of a patient's nose can be
detected and used for assisting fitment of the mask 200 on a
patient.
In some embodiments, the mask 200 includes at least one sensor 226
proximate to the chin portion of the mask 200 and at least one
additional sensor, for example, at least one of the sensors 220,
222, 224.
FIG. 6a illustrates an optional arrangement of sensors on the seal
portion 204. In the optional arrangement of FIG. 6a, the seal
portion 204 includes the plurality of sensors 220, 222, 224
proximate to the nose bridge portion of the mask 200, sensor 226
proximate to the chin portion of the mask 200, as well as
additional sensors, identified as left side plurality of sensors
230 and right side plurality of sensors 232 which, when combined
with sensors 220, 222, 224, and 226, form an approximately evenly
spaced array of sensors extending around the entire periphery of
the seal portion 204. Spacing variations between the sensors on the
order or 1-3 millimeters would be considered as encompassed by the
term "approximately evenly" spaced, although other ranges of
spacings, at greater distances, can also be used and considered as
"approximately evenly" spaced. In such an arrangement, the sensors
can detect and generate signals indicative of forces at a greater
number of locations around the periphery of the seal portion 204.
Thus, such sensor outputs can be used to provide data sufficient
for, for example, a higher resolution mapping of the forces
imparted onto the patient's skin by the seal portion 204.
FIG. 6b illustrates a modification of the seal portion 204
including a different arrangement of sensors. In the embodiment of
FIG. 6b, the seal portion 204 includes a plurality of sensors 222a
proximate to the nose bridge portion, left side plurality of
sensors 230, right side plurality of sensors 232, and sensor 226
positioned to be proximate to a chin of a patient. Additionally,
the seal portion 204 also includes a left side cluster of sensors
231 and a right side cluster of sensors 233, which are positioned
along the sealing surface 205 so as to be proximate to the left and
right sides of a patient's nose. Additionally, as illustrated in
FIG. 6b, the left and right clusters 231, 233 include a plurality
of rows of sensors extending along the length L direction of the
sealing surface 205.
For example, as shown in FIG. 6b, the left side cluster includes an
outer row 231a and an inner row 231b. Similarly, the right side
cluster includes an outer row 233a and an inner row 233b. Including
the plurality of rows of sensors can help improve the detection and
understanding of the sealing effect occurring at locations
including multiple rows of sensors.
For example, in the embodiment of FIG. 6b, the rows 231a, 231b,
233a, 233b are positioned so as to lie approximately at the
transition between the sides of the user's nose and the adjacent
upper cheek portions of the user's face. Such use of additional
sensors and/or a higher density of sensors can provide a benefit of
higher resolution force information. Additionally, such use of
multiple rows of sensors can help a user determine where along the
sealing surface 205 a seal may be generated, for example, more
towards an inner side of the seal portion 204 or more towards an
outer side of the seal portion 204. In some embodiments, such
enhanced force detection ability can help identify and thus resolve
leaks near a patient's eye. For example, the areas of the seal
portion 204 in the vicinity of clusters 231, 233 can result in
leaks which direct air or jets of air toward a user's eyelashes or
eye which can result in discomfort for the patient. Thus, such
additional sensors can be used to help identify and resolve leaks
which may be caused, for example, by insufficient skin
pressure.
FIG. 6c illustrates an optional embodiment of the strap arrangement
212, identified generally by the reference numeral 212a. The strap
arrangement 212a includes an upper strap assembly 240, a lower
strap assembly 242 and a cradle member 244. The cradle member 244
is designed to rest against the back of a patient's head. The upper
strap assembly 240 is configured to connect an upper portion of the
mask 200 to a corresponding upper portion of the cradle member 244
and the lower strap assembly 242 is configured to connect a lower
portion of the mask 200 with a lower portion of the cradle member
244. The upper and lower strap assemblies 240, 242 can include any
number of clips, straps, tensioning devices, etc., as is known in
the art. Additionally, the upper and lower strap assemblies 240,
242 and/or the cradle member 244 can include one or more sensors
configured to detect a force.
For example, the mask 200 can include any arrangement of anchor
points for connection to the strap assembly 212a. In the
illustrated embodiment, the mask 200 includes an upper anchor head
246, a lower left anchor point 248, and a right side lower anchor
point (not shown).
The upper anchor head 246 includes left and right apertures 247,
249 for engagement with tension adjustment assemblies 250. For
example, the upper strap assembly 240 can include a left side
tension adjustment assembly 250 and a right side tension adjustment
assembly 251.
The left and right tension adjustment assemblies 250, 251 include
an engagement end configured to engage with the apertures 247, 249,
respectively. Additionally, the left and right tension adjustment
assemblies 250, 251 include distal ends 252, 253, respectively
configured for engagement with adjustable portions of the upper
strap assembly 240. For example, in the illustrated embodiment, the
upper strap assembly 240 includes adjustable strap portion 254 on
the left end and adjustable strap portion 255 on the right end. In
the illustrated embodiment, the adjustable strap portion 254, 255
can be in the form of any type of strap including an adjustable
fixation device, for example, but without limitation, hook and loop
fasteners. The lower strap assembly 242 can include the same or
similar arrangement of tension adjustment assemblies and adjustable
straps.
Optionally, the upper strap assembly 240 can include one or more
force sensors. For example, the upper strap assembly 240 can
include a force sensor 256 incorporated into the tension adjustment
assembly 250. In some embodiments, the upper strap assembly 240 can
include a sensor assembly 257 including a force sensor disposed on
a different portion of the upper strap assembly 240, for example,
spaced from the adjustable strap portion 254. Similarly, the lower
strap assembly 242 can include a force sensor 256a incorporated
into the tension adjustment assembly 250a and optionally a force
sensor 257a incorporated into the lower strap assembly 242, as well
as sensors at other locations, such as location 257a.
With continued reference to FIG. 6c, the head strap assembly 212a
can optionally include a head sensor 260 configured to detect a
force between the cradle member 244 and a back of a patient's head.
For example, the sensor 260 can be configured to detect a normal or
compressive force at the location schematically illustrated in FIG.
6c. Additionally, optionally, the strap arrangement (e.g., the head
strap assembly) 212 can include an optional neck force sensor 262.
For example, the sensor 262 can be disposed at a lower portion of
the cradle member 244 and can be configured to detect a force
between the cradle member 244 and a neck of a user. For example,
the sensor 262 can be configured to detect a compression between
the cradle member 244 and the neck of a user.
With continued reference to FIG. 6c, the mask 200 can include an
optional conduit tension sensor 264 configured to detect a tension
in the conduit 208. For example, a portion of the conduit 208 can
be formed with the sensor 264 such that the sensor 264 is loaded in
tension when the conduit 208 is subjected to a tensile force in the
direction of arrow T of FIG. 6c.
Each of the sensors of the head strap assembly 212a noted above can
be configured as separate sensor assemblies, each including its own
sensor driver, power supply, and communication device.
Alternatively, all the sensors of the head strap assembly 212a
noted above can be divided into groups, each group connected to a
common sensor driver, power supply, and/or communication device.
Further, optionally, all the sensors noted above can be connected
to a single sensor driver, power supply, and communication device.
The outputs of such sensors can be used, processed, or converted,
for purposes of determining forces, values indicative of forces, or
values having a proportional or other predictable and/or
predetermined mathematical relationship to forces imparted to a
patient's head by way of the strap assembly 212a and mask 200.
Similarly, the output from the sensor 264 can be used to determine
forces associated with tension in the conduit 208. Such information
on the force imparted onto the conduit 208 can also be used to
determine how forces on the conduit 208 affect forces in the strap
arrangement 212 and the mask 200.
With continued reference to FIG. 6c, the mask 200 can include any
of the optional sensor configurations described above.
Alternatively, in some embodiments, the mask 200 includes a sensor
assembly 210 which is configured and positioned to detect forces
acting between the frame portion 202 and the seal portion 204 of
the mask 200. Such a configuration of a sensor is described in
greater detail below with reference to FIGS. 14b, 15a, and 15b.
FIG. 6d illustrates a modification of the mask 200 including a
modified lower left anchor point 248a. In the illustrated
embodiment, the lower left anchor point 248a includes an optional
integrated force sensor 265. The optional force sensor 265 can be
configured to detect a tensile force applied to the lower left
anchor point 248a. For example, the sensor 265 can be positioned
and configured to detect a tensile force (or other forces) imparted
onto the lower left anchor point 248a, for example, by way of a
lower strap assembly 242 (FIG. 6c). Optionally, a lower right
anchor point 248b can also include an optional force sensor
265.
FIGS. 6e-6j illustrate various different optional configurations
for sensors that can be integrated or applied to a head strap
assembly of a mask, for example, the head strap assembly 212a (FIG.
6c). Each of the variations is identified generally by the
reference number 257, generally corresponding to a sensor assembly
corresponding to the sensor assembly 257, and with a letter added
corresponding to the associated figure numbers of FIGS. 6e-6j,
respectively.
With reference to FIG. 6e, the sensor assembly 257e can be in the
form of a detachable sensor unit configured to be releasably
engagable with a portion of the strap assembly 212a, such as the
upper or lower strap assemblies 240, 242. For example, the upper
head strap assembly 240 illustrated in FIG. 6c can include an outer
covering configured to provide releasable engagement with a
fastener, for example, a hook and loop type fastener. Other types
of outer coverings and fasteners can also be used.
Thus for example, the upper head strap assembly 240 can include an
outer fabric like covering including a loop type structure
consistent with a hook and loop type fastener engagement. The
sensor assembly 257e can include a corresponding outer covering,
for example, a hook type structure configured to provide a
releasable engagement with the outer loop type covering of the
upper head strap assembly 240. Additionally, the sensor 257e can
include a sensor 268 configured to detect a tension in the sensor
assembly 257e. For example, the sensor 268 can be configured to
detect tension in the direction of arrow T of FIG. 6e. Thus, when
the upper strap assembly 240 is stretched, the hook and loop
fastener attaching the sensor 257e to the upper strap assembly 240
is also subjected to a tension, thereby imparting a tension onto
the sensor 268. Thus, the sensor 268 can be configured to detect a
force associated with such imparted tension and to output a signal
indicative of such force.
In the configuration of FIG. 6f, the sensor assembly 257f can have
essentially the same construction as the sensor assembly 257e and
can be used to connect two free ends of the upper strap assembly
240.
With reference to FIG. 6g the sensor assembly 257g can include a
sensor 268 disposed within a hollow portion of the associated upper
strap assembly 240. For example, opposite longitudinal ends of the
sensor body 268 can be fixed to spaced apart portions of the upper
strap assembly 240, for example, with stitching, glue, pins, or any
other structure.
FIGS. 6h-6j illustrate further optional configurations for the
incorporation of sensors into strap assemblies. For example, FIG.
6h illustrates an optional configuration in which a sensor assembly
257h is integrated with the upper strap assembly 240 so as to be
exposed on the outer surfaces of the upper strap assembly 240.
Optionally, as shown in FIG. 6i, the sensor assembly 257 can be
disposed within the upper strap assembly 240 so as to be flush with
an outer surface of the upper strap assembly 240, identified as the
sensor assembly 257ie. Alternatively, as shown in FIG. 6i, the
sensor assembly 257ii can be integrated with the upper strap
assembly 240 so as to be flush with the inner surface of the upper
strap assembly 240, and covered on the outer side of the upper
strap assembly 240, with an outer layer thereof.
Further, optionally, FIG. 6j illustrates a configuration in which
the sensor assembly 257j is laminated between the inner and outer
layers of the upper strap assembly 240. Other configurations can
also be used.
FIGS. 6k, 6l, and 6m illustrate optional configurations of clips
that can be used with the strap assembly 212a, for example, in
place of the tension adjustment assemblies 250a, 251, 250a. FIGS.
6k and 6l illustrate one optional configuration, identified
generally by the reference numeral 250k.
As shown in FIGS. 6k and 6l, the tension adjustment assembly 250k
can include a first portion 270, a second portion 271 and a sensor
body 257k connecting the first and second portions 270, 271. The
first portion 270 can include an engagement portion 272 configured
to engage a portion of the mask 200. For example, the engagement
portion 272 can be in the form of a hook shaped member configured
to fit into an aperture, such as the aperture 247 (FIG. 6c). The
first portion can also include a sensor retaining clip 273
configured to fix an end of the sensor body 257k to the first
portion 270.
The second portion 271 of the tension adjustment assembly 250k can
include a further engagement device 274 configured to engage, for
example, a strap of the strap assembly 212a, such as the upper
strap assembly 240 and the adjustable strap portion 254 (FIG. 6c).
For example, the engagement device 274 can include an aperture
configured to receive the adjustable strap portion 254. Other
configurations can also be used. Further, the second portion 271
can include a sensor body engagement portion 275 configured to fix
an end of the sensor body 257k to the second portion 271. As such,
when the tension adjustment assembly 250k is subjected to a tensile
force, for example, in the direction of arrow T, the sensor body
257k is subjected to a tension force. The sensory body 257k can be
configured to output a signal indicative of the tension force
applied thereto.
Optionally, the tension adjustment assembly 250k can include a
driver module portion 277 including, for example, but without
limitation, a sensor driver for the sensor body 257k, a power
supply, and/or a communication device. The driver module portion
277 can be constructed, optionally, in accordance with the
description set forth below with reference to sensor driver 610
(FIGS. 16 and 17).
Optionally, the tension adjustment assembly 250k can include a
pressing boss 278 shaped and configured to maintain alignment and
engagement of the sensor body 257k in the first portion 270. As
illustrated in FIG. 6k, one end of the sensor body 257k fixed to
the first portion 270 can be bent upwardly toward the driver module
portion 277. As such, conductors, leads, wires, etc., connected
with the electrodes of the sensor body 257k can be connected with
the electronics within the driver module portion 277.
FIG. 6m illustrates a modification of the tension adjustment
assembly 250k, identified generally by the reference numeral 250m.
Features, parts, and components of the tension adjustment assembly
250m that are similar or the same as corresponding parts,
components, and features of the tension adjustment assembly 250k
are identified with the same reference numeral, except that a
letter "m" has been added thereto.
With the continued reference to FIG. 6m, the tension adjustment
assembly 250m includes a first portion 270 connected with a first
end of the sensor body 257m and a second portion 271m fixed to a
second opposite end of the sensor body 257m. In the embodiment of
FIG. 6m, the tension adjustment assembly 250m engages the sensor
body 257m with the sensor body 257m in a flat configuration, the
first portion 250m engaging a terminal end of the sensor body 250m
with the first engagement portion 273m. The opposite end of the
sensor body 257m is fixed to the second portion 271m with the
second engagement portion 275m. Conductors (not shown) connecting
the electrodes of the sensor body 257m with the electronics within
the driver module portion 277m can extend from the first end of the
sensor body 257m, upwardly through the first portion 270m, into the
sensor driver assembly 277m. Other configurations and electrical
connections can also be used.
FIGS. 7 and 8 schematically illustrate a further modification of
the masks 100 and 200, and as identified generally by the reference
numeral 300. Parts, features, and components of the mask 300 that
are similar or the same as the masks 200 are identified with the
same reference numeral except that a 100 has been added
thereto.
The mask 300 can be configured to extend only around the mouth of a
patient. Thus, the target area R (FIG. 3) for the mask 300
corresponds to the patient's mouth. The mask 300 includes a frame
302 and a seal portion 304.
With reference to FIG. 8, the seal portion can include one or a
plurality of sensors. For example, the seal portion can include a
sensor 322 disposed at the center of the top portion of the seal
portion 304, configured and positioned to be proximate to the
center of the area of skin between a patient's nose and upper lip
and optionally sensor 326 configured and positioned to lie
proximate to the chin of the user. Optionally, the seal portion can
include a left side sensor 330 and a right side sensor 332.
In further optional embodiments, the seal portion 304 can include
an additional plurality of sensors (not shown) spaced and arranged
relative to the sensors 322, 326, 330, 332 to form a generally
evenly spaced array of sensors around the entire periphery of the
seal portion 304.
FIG. 9 illustrates yet another modification of the mask 100,
identified generally by the reference numeral 400. Parts, features,
and components of the mask 400 that are the same or similar to the
mask 300 are identified with the same reference numeral except that
a 100 has been added thereto.
The mask 400 is configured to function as a nasal pillow mask. As
such, the mask 400 includes a frame portion 402 mounted to a pillow
type nasal seal portion 404.
The seal portion 404 includes two upwardly extending fluid ports,
including a left side fluid port 440 and a right side fluid port
442. The fluid ports 440, 442 extend from the body of the seal
portion 404 upwardly and tapering toward their upper, distal ends.
During use, these fluid ports 440, 442 would extend into the
nostrils of a patient.
FIG. 10 is a skewed top view of the mask 400 as viewed along the
arrow 410. of FIG. 9. As shown in FIG. 10, the sealing surface 405
extends around both of the fluid ports 440, 442 in the area shaped
and configured to contact and seal against the skin surrounding the
nares of a patient.
In some embodiments, the seal portion 404 can include one or a
plurality of sensors. For example, the mask 400 can include a
sensor 422 positioned and configured to lie proximate to the bottom
surface of a distal portion a patient's nose. Optionally, the seal
portion 404 can include a sensor 426 positioned and configured to
lie proximate to the portion of a patient's nares proximate to the
uppermost portion of the patient's upper lip. Additionally, the
mask 400 can include a left side sensor 430 configured to lie
proximate to a left side of a patient's left nostril. Additionally,
the mask 400 can include a right side sensor 432 configured and
positioned to lie proximate to the right side of a patient's right
nostril. Further, optionally, the mask 400 can include an
additional plurality of sensors (not shown), optionally combined
with the sensors 422, 426, 430, 432 to form a generally evenly
spaced array extending around the entire sealing surface 405.
The sensors described above with regard to the fluid delivery
devices (i.e., masks) 100, 200, 300, and 400, can be any type of
force sensor, including load sensors and pressure sensors. In some
embodiments, the sensors described above can be in the form of
dielectric elastomer stretch sensors, which are commercially
available and capable of measuring a range of forces, including
compressive, tension, shear, and bending forces. Dielectric
elastomer stretch sensors can operate as flexible or soft
capacitors. The sensors can also be known as electro-polymer
sensors or elastic capacitive sensors which can also be configured
to measure tension. It is possible to adapt these sensors to
measure other forces, including but not limited to compression,
bending, shear or a combination of forces. Additionally, sensors
can be used in other locations than those identified above. For
example, sensors can be positioned so as to detect force applied to
any delicate area of the skin or delicate area of the face, such as
philtrum, septum, nasal bridge, chin, or any part of the body made
of cartilage or any portion of the face where the skin is proximate
bone.
With reference to FIG. 11, the sensor 500, which can be used as any
of the sensors described above or below, is in the form of an
elastic capacitive sensor. The sensor 500 can be made from a
laminated elastomer structure which enables it to be flexible,
stretchable and compressible. The sensor 500 can include a first
outer surface 502 and a second outer surface 504 and a dielectric
layer 506 comprising an intervening compressible material. For
example, the first and second outer surfaces 502, 504 can be in the
form of conductive silicone. The dielectric layer 506 can be in the
form of nonconductive silicone, or in other words, silicone that
serves as an insulator and can also be referred to as a dielectric
layer 506. Optionally, the entire sensor 500 can be encapsulated in
additional outer layers (not shown) of nonconductive silicone, or
other nonconductive material, so as to encapsulate the sensor
500.
Constructed as such, the outer surfaces 502, 504, made from a
conductive material, such as conductive silicone, carbon black, or
other conductive materials, form the electrodes of a capacitor,
spaced apart and electrically isolated from each other by the
dielectric layer 506. As such the capacitance of the thus formed
capacitor changes along with changes in the shape and/or spacing of
the outer surfaces 502, 504.
For example, as shown in FIG. 12, when the outer surfaces 502, 504
are pressed toward each other so as to reduce the spacing x
therebetween, causing the surface area of the outer surface 502 to
increase and thus increase the capacitance of the sensor 500.
Additionally, when the sensor 500 is subjected to a tensile force
(arrow T), for example, horizontally oriented in FIG. 11, the outer
surfaces 502, 504 are elongated, thereby increasing the surface
area of the electrodes formed by the outer surfaces 502, 504, and
thus increasing the capacitance of the sensor 500. The sensor 500
can be manipulated and/or distorted in other ways that also affect
the capacitance of the sensor 50. These changes in capacitance can
be detected by an appropriate driver, as well known in the art, and
can be optionally converted into a values indicative of or in a
predictable or predetermined mathematical relationship with forces
imparted to the sensors. As such, the sensor 500 detects
deformation of itself and/or, depending on the configuration of the
connection of the sensor 500 to a portion of a mask, the sensor 500
detects deformation of the mask by way of the deformation of the
sensor 500 caused by deformation of the mask.
Elastic capacitive sensors can have several benefits in the context
of the use of respiratory masks. For example, elastic capacitive
sensors can be curved and bent in their neutral position without
changing the output signal of the sensor. This allows the sensors
to conform to three dimensional curvatures of a mask or a patient's
face but not change an output signal until an external force is
applied. This essentially limits bias in the sensors. Measurements
provided by capacitive sensors can be stable and can be less
significantly influenced by bending in the same manner or to the
same degree as resistive sensors. This is a result of the distance
between the laminated layers of the outer surfaces 502, 504
remaining substantially constant when bent. Other sensor types,
such as resistive sensors, can be prone to drift, noise and
temperature or environmental deviations, which make them less
accurate and reliable than elastic capacitive sensors in certain
environments of use.
With reference to FIG. 12a, when not attached to another surface,
an electro capacitive sensor 500 has a neutral axis 510 which
passes through the center of the sensor mass. When bent, one
surface of the sensor, outer sensor 504, will expand while the
other 502 will retract; thus cancelling out the difference of
capacitive change caused by the changes of the outer surfaces 504,
502.
Thus, during manufacturing, such a sensor 500 can be bent (e.g.,
FIG. 12a) to follow the contours of the desired mounting location
of the sensor 500 on a seal portion 204 when the seal portion 204
is in an unloaded, neutral state. Then the sensor can be affixed
(FIG. 12b) to the seal portion 204 in the desired manner with the
sensor 500 also remaining in a neutral state in that its
capacitance is the same or nearly the same as when it is
unbent.
With continued reference to FIG. 12b, after the sensor 500 is
affixed to another surface (e.g., an inner surface of the seal
portion 204), however, the neutral axis 510 is translated to the
plane adjoining the sensor 500 and surface 204. When the sensor 500
is subsequently bent, the fixed surface 504 cannot expand/retract
freely, while a measurable change in surface area will still occur
on the opposite free side of the outer surface 502. This change in
surface area can be measured and correlated to a change in bend
force. As such, the sensor 500 can be optionally configured to
detect a bending force applied to the seal portion 204. For
example, the sensor 500 can be secured to an inner surface of the
seal portion 204, at least partially extending onto the area of the
side wall of the seal portion 204 adjacent to the sealing surface
205. In some embodiments, the sensor 500 is mounted so that it is
positioned on a side wall of the seal portion 204 and spaced from
the sealing surface 205. As such, the output of the sensor can be
considered as an indication of only bending of the seal portion 204
(when sensor 500 is spaced from the sealing surface 205) or as a
combination of bending of the seal portion 204 and compression at
the sealing surface 205 (when it extends onto both the sidewall and
over the sealing surface 205).
With reference to FIGS. 12c-12i, force sensors, such as any of the
force sensors described above, can be formed in different
configurations, which can provide additional benefits.
For example, FIGS. 12c and 12d illustrate a modification of the
sensor 500, identified generally by the reference numeral 550.
Parts, components, and features of the sensor 550 that are the same
or similar to corresponding parts, components, or features of the
sensor 500 are identified with the same reference numeral except
that "50" has been added thereto.
With continued reference to FIG. 12c, the sensor 550 can include a
plurality of layers that are essentially made up of the sensors
500. For example, the sensor 550 can include electrodes 552, 554
arranged in an interleaved manner with dielectric material 556
disposed between each of the electrodes 554, 552 and on the outer
surface of the sensor 550. In such an arrangement, the sensor 550
is essentially a multi-layered, single capacitor, the capacitance
of which changes with deformation, for example, compression,
bending, elongation, etc. Such a multi-layered configuration of the
sensor 550 can provide higher resolution sensing.
In such a configuration, the sensor 550 includes multiple layers of
capacitors laid on top of each other in a configuration in which
they share electrodes which reduces the total thickness of the
sensor 550. This can be beneficial because stacking sensors
provides output resolution as a function of thickness; thus it
becomes possible to keep the thickness of the sensor 550 minimal on
areas of a mask which do not require high resolution, thereby
minimizing surface disturbances of the mask in the vicinity of the
sensor 500 and using thicker layered sensors on areas in which
higher resolution can be beneficial. Such layered sensors 550 can
further dramatically increase the total capacitance of the sensor
550, which not only increases the resolution and range of output
values, but also increases the signal to noise ratio which can lead
to more reliable, consistent, and/or precise output values.
With reference to FIG. 12e, a layered sensor, such as the sensor
550, can be formed through the combination or layering of a
plurality of preformed layered capacitor components, such as
component 560 shown on FIG. 12e, which includes a conductive layer
562 and a dielectric layer 564.
With reference to FIG. 12f, individual pieces of the component 560
can be layered one on top another so as to form the basic capacitor
configuration of two electrodes 562, spaced by a dielectric layer
564. Adding an additional dielectric layer, for example, on top as
viewed in FIG. 12f can be added for encapsulation, as desired. Such
a method of construction of a sensor can provide additional
benefits.
For example, with reference to FIG. 12g, a transversely layered
sensor 570 can be formed with a plurality of units 560. For
example, more specifically, the sensor 570 can include a
longitudinal unit 560L and a plurality of transverse units
560T.sub.1, 560T.sub.2, 560T.sub.3, 560T.sub.4. As described above
with reference to FIGS. 12e and 12f, the units 560L, 560T.sub.1-4
can be arranged so as to create pairs of electrodes 562 spaced by
dielectric layers 564. For example, with reference to FIGS. 12i and
12h, in the vicinity of locations in the sensor arrangement 570 of
FIG. 12g, where the layers 560L and 560T.sub.1-4 overlap, pairs of
electrodes spaced by dielectric layers can be formed. For example,
with reference to FIG. 12h, in the vicinity of the overlapping
areas illustrated in FIGS. 12g and 12i, the unit 560L includes a
lower electrode 562 and an upper dielectric layer 564. As such, the
electrode 562 of the unit 560L provides a common electrode for each
of the individual capacitors formed in the unit 570. For clarity,
each of the overlapping areas of the sensor 570 illustrated in FIG.
12g are identified as 570a, 570b, 570c, 570d.
The upper electrode 562 of each of the sensors 570a-d is formed by
the electrodes associated with the units 560T.sub.1-4. In such a
configuration, the electrode 562L (FIG. 12g) of the unit 560L can
be connected to a driver (not shown) and serve as the electrode for
all of the sensors 570a-d. However, the electrodes
562T.sub.1-T.sub.4, while they can be connected to a single sensor
driver, would normally be read in a serial fashion because using a
common electrode 562L for each of the sensors 570a-570d would
require a serial sampling scheme.
Depending on the mounting location, loading dynamics, and sensor
configuration, including any of the above-described sensors 500,
550, 570, etc., the output of the sensor 500 can be tested against
known loads on the sealing surface 205 to establish a predetermined
relationship between the output of the sensor 500 and loads applied
to the sealing surface 205. In the description set forth below,
force sensors are referred to by the reference numeral 500,
although it is intended that any of the descriptions including
reference to a sensor 500, applies to all of the sensor
configurations described above.
For example, the output signal of the sensor 500 can be fit with a
polynomial curve (e.g., 2.sup.nd order, 3.sup.rd order, 4.sup.th
order, 5.sup.th order, 6.sup.th order, etc.) for defining a
proportional relationship between capacitance values indicated by
the output of the sensor 500 and the force imparted to the sealing
surface 205.
Any of the sensors described above can be integrated with various
different types of seal portions of masks. For example, FIG. 13a is
a schematic cross-section of a portion of the mask 200 in which the
mask 200 is formed of a stiffer frame portion 202, which can be
made from polycarbonate or other more rigid or more flexible
materials and with a silicone sealing portion 204 over-molded onto
a portion of the frame portion 202. For example, more particularly,
the frame portion 202 illustrated in FIG. 13a can include a conduit
connector 206 disposed on a distal portion of the mask 200, and a
proximal portion 207, positioned to lie more proximal to a user's
face during use. The seal portion 204 can include a distal portion
203 that is over-molded onto the proximal portion 207 of the frame
portion 202. The seal portion 204 can include varying geometry, for
example, thicknesses, extending from the distal portion 203 to the
inner edge 209. The sealing surface 205 would normally lie between
the distal portion 203 and the inner edge 209.
In some embodiments, the mask 200 can include an arrangement of the
sensors 500 disposed at the sealing surface 205. For example, FIG.
13b illustrates a sensor 500 mounted to the outer surface of the
sealing surface 205. For example, the sensor 500 can be bonded to,
co-molded or over-molded with the sealing surface 205.
Optionally, the sensor 500 can be partially or fully embedded into
the sealing portion 204. For example, FIG. 13c illustrates the
sensor 500 being partially embedded in the sealing portion 204 so
as to be partially protruding from the sealing surface 205. FIG.
13d, on the other hand, illustrates an optional mounting
configuration of the sensor 500 wherein the outer surface of the
sensor 500 is flush with the sealing surface 205.
The mounting configuration of FIG. 13b can result in the sensor 500
being more responsive to forces applied thereto, for example,
forces resulting in compression of the sensor 500. The arrangement
of FIG. 13d, with the outer surface of the sensor 500 being flush
with the sealing surface 205, can provide better sealing
performance and leak reduction between the user and the sealing
surface 205. The partially protruding configuration illustrated in
FIG. 13c provides a mix of the benefits of enhanced sensitivity
provided by the partially protruding arrangement and the enhanced
sealing and/or leak reduction provided by partially embedding the
sensor 500 into the sealing portion 204.
With reference to FIGS. 14a-14c, the sensors 500 can optionally be
arranged in a dual or "paired" sensor configuration. For example,
with reference to FIG. 14a, pairs of sensors 500 can be mounted to
the sealing portion 204 wherein, for example, outer sensors 500o
are paired with inner sensors 500i, aligned with one another, as
illustrated in FIGS. 14a and b. In the embodiments of FIGS. 14a and
b, the sensors 500o, 500i are mounted to the inner and outer
exposed surfaces of the sealing portion 204, for example, in the
configuration of the mounting of sensor 500 to the sealing surface
205 illustrated in FIG. 13b. Optionally, with reference to FIG.
14c, the sensors 500i, 500o can be mounted as to be partially
embedded (FIG. 13c) or flush mounted (FIG. 13d) with the surfaces
of the sealing portion 204. Optionally, the sensors 500o, 500i can
be mounted in the same position and orientation on the sealing
portion 204. Configured as such, the mask 200 can be placed on a
user's face and tightened so as to cause the seal portion to be
compressed and to bend. As the seal portion 204 distorts, the
sensors 500o, 500i can be deformed and generate a sensor output.
The output of the sensors 500o, 500i will follow a relationship
with the deformation of the sensors 500o, 500i, which can include
bending and compression. Optionally, it may desirable to process
the output from the sensors 500o, 500i so as to isolate
compression. Thus, in some embodiments, the output from the sensors
500o, 500i can be overlaid so as to eliminate the deformation
caused by bending. Thus, the resulting signal will more closely
represent compression applied to the sealing surface 205.
Further, optionally, the sensor 500 can be disposed at the
interface between the frame portion 202 and the seal portion 204.
In such a configuration, the sensor 500 would be loaded more in
compression than other loading.
Optionally, any of the sensors 500 described above can be mounted
and/or connected to a seal support or a foamed or gel sealing
portion. For example, FIG. 15a illustrates a variation of the mask
200 including a support portion 201 connected to the frame portion
202 and shaped and configured to provide structural support to the
sealing portion 204. For example, the support portion 201 can be in
the form of foamed or gel material. Additionally, the support
portion 201 can extend around a limited portion or the entire inner
periphery of the seal portion 204, so as to provide resilient
support for the seal portion 204, to thereby resist collapse of the
seal portion 204 during use.
In some embodiments, a sensor 500 can be mounted at a proximal
portion of the support portion 201, for example, at a position
generally between the proximal end of the support portion 201 and
the inner surface of the seal portion 204. This mounting location
is identified by the reference numeral 500A. Optionally, a sensor
500 can be disposed within the interior of the support portion 201,
for example, at the position identified by the reference numeral
500B. Further, optionally, a sensor 500 can be mounted in between
the support portion 201 and the frame portion 202, in the position
identified by the reference numeral 500C. Optionally, the
embodiment of FIG. 15a can include sensors 500 at any one or any
combination of the locations identified as 500A, 500B, 500C.
FIG. 15b illustrates further modification of the mask 200, in which
the seal portion 204 is formed of a foamed or gel material and is
connected to the frame portion 202. Similarly to the embodiment of
FIG. 15a, the seal portion 204 of FIG. 15b can include any one or a
combination of sensors 500 disposed at various locations, for
example, including a sensor 500 mounted at the sealing surface 205,
in the position identified as 500A, disposed within the seal
portion 204 in the position identified by the reference numeral
500B or at a position between the seal portion 204 and the frame
portion 202, in the position identified as 500C.
As described above, in embodiments where the seal portion 204 are
formed by a foamed or a gel material, the sensors 500 can be
mounted to the exterior of the foamed or gel portion or suspended
within the foam component at a range of depths within the foam or
gel. In such embodiments, the support portion 201 or the seal
portion 204 are made from a compressible foamed or gel material.
The sensors 500 are loaded by displacement of an exterior wall of
the seal portion 204 or the support portion 201 so as to exert
forces on the sensors 500. In such embodiments, the sealing surface
205 can be smoother with less severe or no protrusions, thereby
providing better sealing performance.
In some embodiments, the sensor 500 can have outer surfaces made
from materials that are equal or nearly equal in hardness to the
hardness of the materials used for the sealing surface 205. For
example, in some embodiments of the mask 200, the sealing surface
205 can be made from silicone and the outer surfaces 502, 504 of
the sensor 500 can be made from silicone having the same or
approximately the same hardness (or softness). For example, the
sensor 500, including the outer surfaces 502, 504, the dielectric
layer 506, can be formed with materials, such as silicones, that
have approximately the same or lower Shore hardness value and/or
Young's modulus, than those of the sealing surface 205. As such,
the presence of the sensor 500 is less likely to be perceivable to
the patient.
Further, the sensor 500 and/or any other materials or layers
attached to or encasing the sensor 500 can be made from materials
or in structure that have the same mechanical behaviors (stiffness,
compressibility, rigidity, elasticity) as the seal portion 204,
sealing surface 205, cushion material of the tension adjustment
assembly 250, etc. This can further reduce the likelihood that the
presence of the sensor would be perceivable by a patient and can
reduce or eliminate effects on the functionality or performance of
the sensor 500.
Optionally, one or more of the sensors can be provided with
shielding with non-conductive (dielectric) layer, for example
included in the seal portion 204. For example, shielding with
conductive (and earthed) electrode can help attenuate the effects
of noise from sources such as light bulbs etc. Optionally,
electrodes of the sensor 500 can be made with metalized
(conductive) fabric. In some embodiments, the sensor lead (e.g.,
lead wires) 612 (FIG. 17) from the sensor 500, which can be in the
form of copper wires or other types of conductors, extend past the
silicone to a direct connection with the circuit board of sensor
driver 610.
In some embodiments, the seal portion 204 can include an integrated
anchoring point for the sensor 500. For example, the seal portion
204 can include an embedded bead or cord forming a thicker section
that serves as an attachment point. Additionally, the seal portion
204 can include embedded elasticated fabric to increase the
tear-strength. Optionally, embedded fabric can be included to act
as over-stretch limiter.
Further, the seal portion 204 can include elasticated inlay
(fabric) to modify the spring constant of the seal portion 204
and/or the sensor 500. This allows tuning the elongation at a given
load.
With reference to FIG. 16, any of the fluid delivery devices
described above can be incorporated into a fitment system which can
optionally be integrated with a therapeutic fluid delivery supply.
For example, with reference to FIG. 16, a mask fitment system 600
is illustrated as being integrated with a therapeutic fluid
delivery supply 602. The mask fitment system 600 can include any of
the fluid delivery devices described above, however, for brevity,
device 100 is identified and represented schematically in FIG.
16.
The fluid delivery conduit 108 is connected to a therapeutic fluid
delivery supply 602, which can be any type of therapeutic fluid
delivery device, such as a C-pap machine, or any other kind of
ventilation, respiration, gas, liquid or therapeutic solid delivery
system. The fluid delivery conduit 108 is connected to the
therapeutic fluid delivery supply 602 with a connector 604 which
leads to a therapeutic fluid source 608.
The sensor 110 schematically represented in FIG. 16 represents one
or a plurality of sensors in any of the arrangements and/or
configurations described above. The sensor 110 can be connected to
a sensor driver 610, which in the illustrated embodiment, is
integrated into the therapeutic fluid delivery supply 602. The
sensor 110 is connected to the driver 610 with a sensor lead 612.
The sensor lead 612 is intended to represent one or a plurality of
leads, one lead for each of the sensors 110.
The driver 610 can be any type of commercially available sensor
driver. In some embodiments, where the sensors 110 are in the form
of elastic capacitive sensors, the driver 610 can be in the form of
a commercially available sensor module. In the illustrated
embodiment, the driver 610 is configured for a wired connection to
the sensors 110 through serial type data wire bundle.
The driver 610 can be configured to output a signal, in the form of
data, which can include numerical values indicative of the
capacitance of the connected sensors 110, in a predetermined
relationship to forces or pressures imparted onto the sensors 110.
The output of the driver 610 can be processed, with predetermined
mathematical relationships, such as optionally polynomial fits
noted above, into data indicative of a pressure or force detected
by the sensors 110 or values that have a predictable or
predetermined mathematical relationship with the forces detected by
the sensors 110. Optionally, such data output from the driver 610
can be fed to a display device 620 configured to display
representation of the forces detected by the sensors 110.
For example, optionally, the display device 620 can be configured
to display a graphical representation of the mask 100 and force
values presented with the graphical representation of the mask,
with the force value representations spatially correlated to the
locations of the sensors 110 on the mask 100. Such optional display
formats are described in greater detail below with reference to
FIGS. 20 and 21.
FIG. 17 illustrates a modification of the mask fitment system 600,
identified generally by the reference numeral 700. The fitment
system 700 transmits sensor data wirelessly, as described
below.
As shown in FIG. 17, in the fitment system 700, the sensor driver
610 is mounted on the mask 100, along with a power supply 702. The
sensor driver 610 receives a signal from the sensor 110 through the
sensor lead 612. In this embodiment, the sensor driver 610 is
configured to wirelessly transmit a signal 704 indicative of the
capacitance of the sensor 110. Optionally, the driver 610 can be in
the form of a commercially available sensor driver with wireless
connectivity.
The fitment system 700 can include a display device 706 configured
to receive the wireless signal 704 and display a representation of
the forces detected by the sensor 110. Optionally, the display
device 706 can be in the form of a handheld computing device, such
as any of a large number of smart phones which are currently widely
commercially available, operating on an Android.TM. and iOS
platforms. However, other types of wireless enabled display devices
can also be used.
With reference to FIG. 18, the display devices 620 or 706 can be
configured to display representations of the detected forces in
various different formats. For example, as shown in FIG. 18, the
display device 706 can be configured to display a graphical
representation of the mask 200, corresponding to a front
elevational view of the mask 200. Additionally, the display device
706 can be configured to display representations of the detected
forces at locations spatially or positionally correlated or
corresponding to the locations of the sensors 220, 222, 224, 226,
230, 232.
For example, the display device 706 can be configured to output a
representation of the force detected by the sensor 220 (FIG. 6a) at
representation 720. Similarly, the display device 706 can be
configured to output representations from the sensors 222, 224, 226
at positions corresponding to representations 722, 724, and 726,
respectively. Similarly, the display device can be configured to
display representations of the plurality of sensors 230, 232 at the
positions of representations 730, 732, respectively.
The representations 720, 722, 724, 726, 730, 732 can be in any
format including numerical, iconic, color coded, or any desired
format. Additionally, the position of the representations 720, 722,
724, 726, 730, 732 can be disposed on top of the graphical
representation of the mask 200, or in any other desired
location.
With the representations arranged in positions that generally
correspond to the locations of the sensors, a user can more readily
understand how to adjust a mask 200 based on the representations of
the detected forces. In the display of FIG. 18, the graphical
representation of the mask 200 is in a front elevational view
orientation. Thus, a healthcare worker attempting to put the mask
200 onto a patient would see the representations of the forces in a
way that corresponds to that person's view of the mask 200 which
would also be in a front elevational orientation.
Using the representations of the forces as shown in FIG. 18, a
healthcare provider could observe the representations of the
forces, then adjust the mask 200 to achieve the most uniform force
distribution around the periphery of the mask 200 as possible with
the lowest magnitude of forces and with an acceptable leak
rate.
With reference to FIG. 19a, optionally, the display device 706 can
be configured to display a representation of the mask 200 in a rear
elevational view. In this orientation, the representations 720 and
732 are disposed on the right side of the screen and the
representations 724 and 730 are disposed on the left side of the
screen. This orientation would be helpful to a patient attempting
to fit the mask 200 on their own face.
FIG. 19b illustrates yet another optional format for the display of
force information. In the embodiment of FIG. 19b, the display
device 706 is configured to generate a three dimensional map 750
including a graphical representation of force data 752
corresponding to the output of sensors. For example, the map 750
can include a plane 754 corresponding to a zero force, and positive
force values can be represented as extending upwardly, normal to
the plane 754. In the illustrated embodiment of FIG. 19b, two
maximum pressure locations 756, 758 are illustrated as two peaks on
the three dimensional map. These representations 756, 758 can be
considered to be exaggerated examples of displayed force
information that could correspond to the output of sensors
corresponding to the representations 720, 724, described above.
With reference to FIG. 19c, the display 706 can be configured to
display force data in a radial pattern, schematically corresponding
to the layout of sensor representations 720-732 described above
with reference to FIGS. 18 and 19a. In the optional format of FIG.
19c, the display 706 displays the force data in the form of a
radial, color coded graphical representation in the form of a
radial pattern 760. For example, the radial format 760 can include
a legend 762 providing a color gradation corresponding to a range
of forces or pressures. Additionally, the display 706 can be
configured to color code geometric shapes around the radial format
760 with the geometric shapes, such as rectangles, filled in with
colors corresponding to the legend 762. Additionally, the radial
format 760 can include a reticle 764 which can be represented in a
position within the radial format 760 indicating a balance point.
For example, the reticle 764 can be in the form of a cross. When
the reticle 764 is represented in the center of the radial format
760, such a position would indicate that the pressures represented
around the periphery of the radial format 760 are roughly in
balance with each other. However, if higher pressures or forces are
detected on one side of the associated mask, the reticle 764 can be
displayed in an off center location. As such, the reticle 764 can
provide guidance for a user for rebalancing the forces around the
mask.
With reference to FIG. 19, a modification of the radial format 760
is illustrated therein and identified generally by the reference
numeral 760a. In the format 760a of FIG. 19b, force data can be
selectively represented in a more emphasized way to illustrate
imbalance. For example, as shown in FIG. 19d, some of the values
associated with the plurality of positions of representation 732
are represented with colored blocks. Additionally, the reticle 764
is presented in a location offset from center, positioned closer to
the plurality of positions of representation 732. Thus, a user can
interpret this representation as indicating that there is excessive
force on the portion of the mask 200 corresponding to the sensor
location 732. Thus, if the user adjusts the associated mask 200 so
as to achieve more balanced forces around the periphery of the
mask, the reticle 764 can be moved towards the center of the radial
format 760a, and the display of the selected blocks within the
plurality of position 732 can be deleted.
FIG. 19e illustrates an optional horizontal bar graph display
format 766. In this optional display format 766, force information
is represented as vertically extending bar graphs, with the sensor
representations 720, 722, 724 represented in approximately the
center of the graph, the left side plurality at representation 730
is displayed on the left side of the graph and the right side
plurality at representation 732 is disposed on the right side of
the graph, and the chin location representation 726 plotted
optionally on both the left and the right ends of the bar graph. As
such, the format 766 provides another optional format for
illustrating the balance of forces around the periphery of a
mask.
FIG. 19f illustrates another optional display format 770, in the
form of a vertically split bar graph. In the illustrated embodiment
format 770, the left side plurality of sensor representation 730
are displayed in the form of variable length bars extending from
the center of the format 770 to the left and the right side
plurality at representation 732 are displayed as horizontal bars
extending from the center of the format 770, towards the right.
Optionally, the bars associated with the location of
representations 730, 732, as well as the other sensor locations,
can be color coded. In one example of the display in the format
770, the right side plurality at representation 732 are displayed
in a different color than that used for displaying the location of
representation 730, thereby indicating excessive force on the right
side of the mask 200. A user can thus use such a display to reduce
the pressure on the right side or increase the pressure on the left
side of an associated mask 200 to thereby achieve a more balanced
fitment.
FIG. 19g illustrates another variation of a radial layout,
identified by the reference numeral 774. In the format 774, force
data is represented in radial bars, extending from the inner ends
of the bars which follow and enter periphery 776. Increase in
pressures are displayed as corresponding to individual bars having
an increasing radial length. For example, in the embodiment of FIG.
19g, the bars associated with the sensor representation 726,
proximate to a user's chin, are illustrated as detecting a higher
force than the sensor at representation 722 associated with a
position proximate to a user's nose bridge. As noted above, the
various different formats can incorporate color coding, three
dimensional shapes, or bar lengths so as to graphically illustrate
the detected forces and also to provide prompts to a user for
achieving a better fit of an associated mask.
FIG. 20 illustrates yet another embodiment of a mask fitment
system, identified generally by the reference numeral 800. The
fitment system 800 includes a display device, such as LEDs 802
disposed on the mask, in this embodiment, the mask 200, however, it
is to be understood that the mask fitment system 800 can comprise
any of the masks described above.
The fitment system 800 can include a sensor and display driver 801
disposed anywhere on the mask 200, for example, on the frame
portion 202.
As shown in FIG. 22, the sensor and display driver 801 can include
the sensor driver 610, described above, and a power supply 702
connected to the driver 610. Additionally, the sensor and display
driver 804 can include a display driver unit 804.
The display driver unit 804 can be configured to receive the output
of the driver 610 either by serial lead 806 or by wireless signal.
The display driver 804 can include math processing circuitry or
software configured to convert the signals received from the driver
610 into a light driver signal, such as an LED light driver
signal.
The output from the display driver 804 can be connected to one or a
plurality of LEDs 802. For example, with or without limitation, the
LEDs 802 can be in the form of RGB LED lights. Additionally, the
display driver 804 can be in the form of an RGB LED light driver.
Additionally, the driver 804 can include circuitry or programming
to output a signal to the LEDs 802 so as to change the color of the
light output from the LEDs 802 in a predetermined proportional
relationship to the signals received from the driver 610. For
example, values indicative of low forces received by the driver 804
can be converted into light blue color signals delivered to the
LEDs 802, thereby causing the LEDs 802 to emit a light blue color.
On the other hand, the supply driver 804 can be configured to
output red light signals to the LEDs 802 in response to signals
from the driver 610 indicative of high forces. As such, during
operation, when a healthcare worker is looking at a patient wearing
the mask 200, the healthcare workers will see red lights in areas
where higher pressures are detected and blue lights in the areas
where lower pressures are detected. The healthcare worker can then
adjust the mask 200 in order to achieve a uniform pressure around
the mask 200 with the lowest magnitude of forces and an acceptable
leak rate. Additionally, if a patient attempted to fit the mask on
themselves, by looking in a mirror, they would also see colors of
lights in the correct orientation to understand how to adjust the
mask.
FIG. 22 illustrates a method that can be employed using any of the
masks or fitment systems described above, although for brevity, the
following description refers to one or both of the fluid delivery
device 100 and the mask 200 in the descriptions of some examples.
In the flow chart of FIG. 23, the method begins at operation block
900. In the operation block 900, a fluid delivery device, such as a
mask 200, or any of the other masks disclosed herein, can be fit
onto a patient. After the operation block 900, the method can
proceed to operation block 902.
In the operation block 902, forces can be detected at one or more
locations where the fluid delivery device contacts the patient. For
example, any of the arrangements, layouts, or configurations of the
sensor 500 on any of the masks described above can be used to
detect forces, which may be indicative of forces imparted onto an
area of the patient AS (FIG. 3). After the operation block 902, the
method can proceed to operation block 904.
In the operation block 904, the outputs from the sensors can be
processed. For example, outputs from any of the sensors described
above can be input to an appropriate driver, such as the driver 610
(FIGS. 16 and 17). Additionally, the output from the sensors can be
converted to output such as data having a predetermined
relationship to the forces detected by the sensors in operation
block 902. For example, the driver 610 can be configured to receive
output from the sensors 500 and output one or more signals
representative of the capacitance of the sensors where the sensors
are capacitive sensors. Optionally, in operation block 904, the
output of the sensors can be further processed into the desired
units such as force units, pressure units, load units, or other
units. Further, optionally, in the operation block 904, the output
from the sensors can be further converted into data that can be
used by a display device for presenting representations of the
forces detected by the sensors. After the operation block 904, the
method can move on to operation block 906.
In the operation block 906, data based on the output from the
sensors can be stored. For example, the data generated in operation
block 904 can be stored continuously, in batches, selectively,
sampled at intervals, or any other desired storage technique.
Additionally, the method can continue from operation block 904 to
operation block 908.
In the operation block 908, data generated in the operation block
904 can be displayed to a user. For example, the data generated in
operation block 904 can be displayed on a graphical monitor, a
mobile computing device, or any other type of device. Additionally,
for example, the data generated in operation block 904 can be
presented in the formats represented in FIG. 18 or 19a-g, or any
other desired format. Additionally, the display device used in
operation block 908 can be configured to present a user interface
allowing a user to select the options of representing the data in
the formats of FIG. 18 or 19a-g or any other format. After the
operation block 908, the method can move to operation block
910.
In the operation block 910, a user, including the patient or a
clinician such as a nurse or sleep technician, can take responsive
action to the information output in operation block 908. For
example, if the information displayed in the operation block 908
indicates uneven or excessive pressure on a portion of the mask,
the user can adjust the mask with the goal of reducing pressure,
reducing the magnitude of pressure force differentials, and
achieving an acceptable leak rate. Adjustment of the mask 200 can
include adjustment of the orientation of the straps of the strap
arrangement 212 and/or other adjustments of the frame portion 202
and/or seal portion 204. After the operation block 910, the method
can return to operation block 902 and repeat until the desired
fitment is achieved.
With continued reference to FIGS. 3, 16 and 17, after the desired
fitment of the fluid delivery device 100 is achieved, the use of
the fluid delivery device 100 can continue with the delivery of a
therapeutic fluid from the therapeutic fluid delivery supply 602,
through the conduit 108, to the target area R.
Optionally, execution of any combination of the operations of
operation blocks 902, 904, 906, 908, 910 can repeat and continue
during the delivery of a therapeutic fluid. As such, the care of
the patient can include and benefit from the data output from the
one or more sensors 110 on the device 100, or the processing of
that data, to further improve patient comfort and leak management.
Additionally, data stored in operation block 906 can be used to
identify causes of inadvertent injuries or non-optimal
effectiveness of the therapy. For example, if a patient receives
therapy for long periods of time such as CPAP therapy while
sleeping or unconscious or non-lucid patients receive NIV therapy,
stored pressure data (collected in operation block 906) may reflect
changes in forces at the sealing surface 105 consistent with the
appearance of an injury, perceived discomfort, or non-optimal
effectiveness of the therapy.
A number of examples of therapeutic fluid delivery device aspects
of the interfaces, and variations on each aspect, have been
discussed with reference to other Figures. The present application
contemplates that a therapeutic fluid delivery device may
incorporate some aspects but not other aspects. For example, a
therapeutic fluid delivery device might incorporate aspects of a
mask while using a different arrangement for securing the mask to
the user. All of these variations are considered within the scope
of this application.
Although the present inventions are disclosed in terms of certain
embodiments, other embodiments apparent to those of ordinary skill
in the art also are within the scope of these inventions. Thus,
various changes and modifications may be made without departing
from the spirit and scope of the inventions. For instance, various
components may be repositioned as desired. Moreover, not all of the
features, aspects and advantages are necessarily required to
practice the present inventions. Accordingly, the scope of the
present invention is intended to be defined only by claims herein
or claims submitted at a future date.
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